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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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FDA: "The Voice of the Patient” CFS and ME Meeting Report

Discussion in 'General ME/CFS News' started by Ember, Sep 19, 2013.

  1. Ember

    Ember Senior Member

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    I just received this email from the FDA announcing the publication of "The Voice of the Patient" CFS and ME Meeting Report:
  2. Bob

    Bob

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    Thanks for posting this, Ember.

    Has anyone got around to reading this yet? What do you think?
    I think it's exceptional. It might be the most comprehensive, detailed and insightful description of my illness that I've ever read. I think it demonstrates a deep insight into the illness, and I was quite moved, emotionally, when reading it.

    This is the link for the PDF document:
    http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf
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  3. Jonathan Edwards

    Jonathan Edwards Board Member

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    From my different viewpoint, I agree this seems a very positive and helpful document. I just wonder how society has got so screwed up with capitalism that the address is 'Dear Stakeholder'. Is life just being a 'stakeholder'? Is being ill just being a 'stakeholder' (in the illness?)? Maybe the physicians who really do consider themselves stakeholders in illnesses just forgot it's a bit different for patients? But I am being churlish and unfair here. The text transcends the opening and looks to me like a lot of sensible people saying a lot of sensible and useful things. I have only being thinking about ME for 3 months but I can't help thinking this is new at this level - I'd be interested to know what people think.
  4. peggy-sue

    peggy-sue

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    I find this comment a little disturbing:
    "It is clear that CFS and ME is a debilitating disease."

    Is this just a whole load of bad grammar?
    Is it a couple of typos?
    Is it another attempt to rename things? (from CFS/ME to CFS + ME)
    Does it even distinguish between ME and CFS?

    Legal judgements could depend on "something like this" getting through documents. :cautious:
  5. Bob

    Bob

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    I don't remember having ever seen anything like this organised by a government agency. I think it's the first time I've ever seen an establishment body (e.g. a government agency or a health authority) actually 'listen' to patients' experiences, in an in-depth consultation, and then describe ME/CFS on the basis of that consultation. (So often, we have to read such nonsense by vested interests who describe an illness that we don't recognise, and the vested interests have a broad influence, and publish a lot of 'scientific' literature.) I'm not sure how this FDA document might be interpreted by someone who hasn't any existing insight into ME/CFS. I've got to read it again with a more critical eye.
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  6. Bob

    Bob

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    They do explain their terminology:
    So they are not making a judgement about whether they have investigated a single disease.
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  7. Sasha

    Sasha Fine, thank you

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    Part of the process by which this was arrived at seemed pretty extraordinary, to my British eyes. This FDA meeting (which was livestreamed) is the second forum (the other being the twice-yearly livestreamed meetings of the CFS Advisory Committee to the US DHHS) in which I've seen testimony invited from patients, who phone in or give testimony from the floor in five-minute slots and often use it to tell people what it's like to live with the disease. I've seen people on the committees crying during this kind of testimony (though famously in the case of CFSAC, nothing then happens).

    I find it hard to imagine either such positive involvement of patients (who are also free to make policy points) or such an open parade of suffering at a UK committee (I'm not sure our culture is geared up to hear it). It amazes me that the latter should be necessary in this day and age - almost as though we have to prove that we are the 'deserving poor'. I always watch it with a great deal of ambivalence - admiration for the guts it takes to stand up and put yourself through giving that kind of distressing testimony on the one hand, and a kind of horror that we should have to parade our wounds like this to get heard.

    Possibly slightly off the topic of your question but perhaps interesting, nonetheless.
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  8. Lynn

    Lynn Senior Member

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    Okay this is obscure. In the movie Miracle on 34th Street, a judge ruled that Kris Kringle was officially Santa Claus because the United States Post Offices delivered a bunch of letters to him in court. One government agency recognizing the authority of another federal agency. Very far fetched but I wonder if there isn't a grain of truth there?

    This FDA document is one federal agency recognizing the seriousness of our illness. Perhaps it will help our cause against HHS if we reference the FDA document in our letters to our congressmen regarding the HHS contract to define our illness.

    Lynn
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  9. Firestormm

    Firestormm Guest

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    :snigger: I had this same conversation with my local NHS Board in 2012 I think. They started calling patients 'service users'. Drove me round the bend! Of course the NHS and Govt. do not want us to consider ourselves 'patients' implying some stationary and obligatory position: they would rather we considered ourselves simply as 'passing through' :D

    I think - trying to be fair - that this email was sent to various people who all had a 'stake' in the proceedings and outcomes. But yeah, I think it's silly.

    And I need a break....
  10. Firestormm

    Firestormm Guest

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    Ember thank you so much for posting this. I have downloaded and only thus far skimmed it, but am on a par with Bob at this point. I think it is very good. Now, if only a similar event could be hosted in the UK by our regulatory players... :whistle:
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  11. peggy-sue

    peggy-sue

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    Thanks for this;
    "
    peggy-sue said:
    I find this comment a little disturbing:
    "It is clear that CFS and ME is a debilitating disease."​
    They do explain their terminology:
    On April 25, 2013, FDA held a public meeting to hear perspectives from patients with chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) about their disease, its impact on their daily life, and currently available therapies. For this meeting and summary report, the terms CFS, ME, and CFS and ME are used interchangeably in describing the conditions.1
    CFS and ME is a serious disease or set of diseases for which there are currently no FDA-approved therapies.
    ...
    1 The terms CFS and ME are intended to be inclusive and make no judgment on the cause of different symptom complexes. At this time, FDA does not endorse any particular disease definition​
    So they are not making a judgement about whether they have investigated a single disease."

    from Bob

    well, ok, I did have a good go at reading the whole thing but it was an awful lot of words, it was, honest...:alien:
    I am still left thinking; "Well, they could still have done better with their grammar."
    (sorry. not good brain-wise and very, very grumpy.)
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  12. Bob

    Bob

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    I know the feeling!
  13. rosie26

    rosie26 Senior Member

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    That was a long read. I was impressed. It was a real description of the illness. Taken seriously.


    "Stakeholder" very odd. I had a quick look at this thread lastnight and "stakeholder" actually put me off reading any further lastnight. !
  14. Ember

    Ember Senior Member

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    In light of her recent decision, perhaps Dr. Unger should note that “it was their collective experience with acute, debilitating PEM, which participants called a 'crash' or 'collapse,' that received the most attention at the meeting:”
    Why measure physical crashes with cognitive tests?
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  15. Firestormm

    Firestormm Guest

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    Not sure if that's rhetorical but it could be useful to measure against mental pem - to see if there is a difference? Not that Unger is proposing to overstimulate people mentally and observe: but someone else might and I think should. I know we tend to get very invested in the physical but more attention should be paid to mental exertion and exhaustion/pem.
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  16. Ember

    Ember Senior Member

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    Yes, the question was rhetorical. Confounding variables, such as are contemplated here, may wash out her results:
    Notice too how single CPET test results are described in this study:
    We have good reason "to get very invested in the physical."
  17. Bob

    Bob

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    The UK's biggest patient charity, Action for ME, has commented on the document.

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